2023-503698-40-00招募中3 期
Aspirin versus placebo in twin pregnancies for preeclampsia prevention: A multicentre, randomised, double-blind, placebo-controlled trial (ASPRE-T)
Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia17 个研究点 分布在 7 个国家目标入组 498 人开始时间: 2023年3月9日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 498
- 试验地点
- 17
- 主要终点
- To determine if the prophylactic use of low-dose aspirin from the first-trimester of pregnancy in women with twin pregnancy can reduce the incidence of PE with delivery <37 weeks’ gestation.
研究概览
简要总结
To determine the effect of low-dose aspirin on theincidence of preterm preeclampsiawith delivery <37 weeks’ gestation.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years.
- •DCDA or MCDA twin pregnancies.
- •Both live fetuses at 11+2-13+6 weeks of gestation.
- •Informed and written consent.
排除标准
- •Monoamniotic twins.
- •Patients who are suffering from known gout, severe hepatic impairment or severe renal impairment.
- •Hypersensitivity to salicylic acid compounds or prostaglandin synthetase inhibitors (e.g. certain asthma patients who may suffer an attack or faint and certain patients who may suffer from bronchospasm, rhinitis and urticaria) or to any excipients (see section 6.1 of the SmPC for details).
- •Patients on long term non-steroidal anti-inflammatory medication.
- •Not fluent in local language and absence of interpreter.
- •Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol.
- •Triplet pregnancies that had undergone embryo reduction to twins or with one vanishing twin.
- •Pregnancies complicated by major fetal abnormality or nuchal translucency thickness >3.5 mm identified at the 11+2-13+6 weeks scan.
- •MCDA twin pregnancies in which there are early signs of TTTS or sFGR defined by a 20% discordance in CRL at the 11+2-13+6 weeks’ scan.
- •Those who lack capacity and who are unable to provide informed consent to take part.
- •Women taking low-dose aspirin regularly (administration must have ceased >7 days prior to randomization).
- •Participation in another drug trial within the previous 7 days.
- •Haemorrhagic diathesis; coagulation disorders such as haemophilia and thrombocytopenia or concurrent anticoagulant therapy.
- •Active or history of recurrent peptic ulceration and/or gastric/intestinal haemorrhage, or other kinds of bleeding such as cerebrovascular haemorrhages.
结局指标
主要结局
To determine if the prophylactic use of low-dose aspirin from the first-trimester of pregnancy in women with twin pregnancy can reduce the incidence of PE with delivery <37 weeks’ gestation.
To determine if the prophylactic use of low-dose aspirin from the first-trimester of pregnancy in women with twin pregnancy can reduce the incidence of PE with delivery <37 weeks’ gestation.
次要结局
- To determine the effect of low-dose aspirin on the incidence of (stratified according to chorionicity): Delivery with PE at <32 weeks, <34 weeks, <37 weeks and at any gestation.
- Gestational hypertension (GH)
- Birth at <32 weeks, <34 weeks and <37 weeks (Spontaneous, Iatrogenic for PE, GH or FGR, Iatrogenic for other reason).
- Death of one twin and / or both twins before discharge from hospital: Miscarriage of the whole pregnancy or death of one twin <24 weeks’ gestation, Stillbirth or neonatal death of one or both twins at <32 weeks, <34 weeks, <37 weeks and at any gestation.
- Birthweight <3rd, <5th and <10th percentile for gestational age
- Placental abruption (clinically or on placental examination) at <32 weeks, <34 weeks, <37 weeks and at any gestation.
- Postpartum hemorrhage (defined as blood loss ≥1 L within the first 24 hours after birth)
- Neonatal morbidity: Intraventricular hemorrhage (IVH) grade II or above : Grade II – IVH occupies <50% of the lateral ventricle volume. Grade III – IVH occupies ≥50% of the lateral ventricle volume. Grade IV – Hemorrhagic infarction in periventricular white matter ipsilateral to a large IVH. Neonatal sepsis. Encephalopathy grade. Neonatal seizures. Anemia. Respiratory distress. Necrotizing enterocolitis requiring surgical intervention. Composite of any of the above.
- Neonatal therapy: Neonatal intensive care unit admission, Ventilation defined as need of positive pressure (continuous positive airway pressure (CPAP) or nasal continuous positive airway pressure (NCPAP) or intubation, Length of stay in neonatal intensive care unit o composite of any of the above
- Features of severe PE including: Stroke, Eclampsia, systolic blood pressure >160 mmHg on at least one occasion, diastolic blood pressure >110 mmHg on at least one occasion, respiratory failure requiring intubation or mechanical ventilation, myocardial ischemia or infarction, pulmonary edema, hepatic dysfuncion, hepatic hematoma or rapture, platelet count <100 x 109/litre
- Features of severe PE including: abnormal liver function enzymes (ALT or AST >67 iu/litre), acute kidney injury, creatinine >150 μmol/L, cortical blindness, retinal detachment, transfusion of any blood products, HELLP syndrome, placental abruption, postpartum hemorrhage (defined as blood loss ≥1 L within the first 24 hours after birth), intensive therapy or high-dependency unit admission.
- Features of severe PE including: confirmed sepsis (positive blood or urine cultures) up to post-natal discharge, total number of nights in hospital.
研究者
Catalina de Paco Matallana
Scientific
Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
研究点 (17)
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